BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT¿ II SYRINGE

    MDR report key: 7245480 · Received February 6, 2018

    Report

    Report Number
    3002682307-2018-00008
    Event Type
    Malfunction
    Date Received
    February 6, 2018
    Date of Event
    January 11, 2018
    Report Date
    January 16, 2018
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY AN INVESTIGATION WAS COMPLETED WITH THE AFFECTED SAMPLES AND 17 REFERENCE SAMPLES. A LEAKAGE THROUGH THE PLUNGER ROD WAS OBSERVED IN THE SAMPLE AND ONE REFERENCE SAMPLE. THIS VERIFIES THE REPORTED ISSUE AFTER THE EVALUATION OF THE PLUNGER WITH MAGNIFICATION. WE HAVE REVIEWED OUR PRODUCTION AND INSPECTION RECORDS AND HAVE ESTABLISHED THAT ALL PRODUCTION AND QUALITY PROCESSES WERE CARRIED OUT NORMALLY. NEITHER QA NOR NCMR'S. SYRINGES WERE PACKED IN MACHINE (B)(4) (SEPTEMBER 5 - 6TH, 2017). SYRINGES WERE ASSEMBLED IN MACHINE, (B)(4), IN LOT #7234166 (AUGUST 23 - 28TH, 2017) AND LOT #7244145 (SEPTEMBER 4 - 11TH, 2017). RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. WE HAVE ALSO REVIEWED THE BARRELS LOTS #7244050, #7237224, #7234192, AND #7211166 AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. WE HAVE ALSO REVIEWED THE PLUNGER LOTS #7244051, #7237228, #7234196, #7211170, AND #7198289 AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. WE CONCLUDE THAT THE CAUSE OF THE PROBLEM WAS PRODUCED AS A CONSEQUENCE OF A DAMAGE IN THE PLUNGER LIP. THIS COULD BE PRODUCED DURING THE HANDLING OF THE PRODUCT THROUGH THE MANUFACTURING PROCESS OR IN THE PLUNGER ASSEMBLY MACHINE. BASED ON AN EVALUATION OF SEVERITY AND OCCURRENCE IT WAS DETERMINATE THAT NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. INVESTIGATION CONCLUSION. SAMPLE EVALUATION. WE HAVE BEEN PROVIDED WITH THE AFFECTED SAMPLE AND 17 REFERENCE SAMPLES. A LEAKAGE THROUGH THE PLUNGER ROD WAS OBSERVED IN THE AFFECTED SAMPLE AND ONE REFERENCES PROVIDED SAMPLE. AFTER THAT WE COULD DETERMINATED A DAMAGED IN THE PLUNGER ROD BY THE EVALUATION OF THE PLUNGER WITH MAGNIFICATION. BHR REVIEW. WE HAVE REVIEWED OUR PRODUCTION AND INSPECTION RECORDS AND HAVE ESTABLISHED THAT ALL PRODUCTION AND QUALITY PROCESSES WERE CARRIED OUT NORMALLY. NEITHER QA NOR NCMR'S. SYRINGES WERE PACKED IN MACHINE (B)(4) (SEPTEMBER 5 - 6TH, 2017). SYRINGES WERE ASSEMBLED IN MACHINE, (B)(4), IN LOT #7234166 (AUGUST 23 - 28TH, 2017) AND LOT #7244145 (SEPTEMBER 4 - 11TH, 2017). RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. WE HAVE ALSO REVIEWED THE BARRELS LOTS #7244050, #7237224, #7234192, AND #7211166 AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. WE HAVE ALSO REVIEWED THE PLUNGER LOTS #7244051, #7237228, #7234196, #7211170, AND #7198289 AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. ROOT CAUSE DESCRIPTION. ROOT CAUSE ANALYSIS. WE CONCLUDE THAT THE CAUSE OF THE PROBLEM WAS PRODUCED AS A CONSEQUENCE OF A DAMAGE IN THE PLUNGER LIP. THIS COULD BE PRODUCED DURING THE HANDLING OF THE PRODUCT THROUGH THE MANUFACTURING PROCESS OR IN THE PLUNGER ASSEMBLY MACHINE. WE CONCLUDE THAT THE CAUSE OF THE PROBLEM WAS PRODUCED AS A CONSEQUENCE OF A DAMAGE IN THE PLUNGER LIP. THIS COULD BE PRODUCED DURING THE HANDLING OF THE PRODUCT THROUGH THE MANUFACTURING PROCESS OR IN THE PLUNGER ASSEMBLY MACHINE. CONFIRMATION. THE PROVIDED SAMPLES PRESENTED THE REPORTED ISSUE. WE COULD CONFIRM THE REPORTED ISSUE. CAPA DETERMINATION. NO - BASED ON AN EVALUATION OF SEVERITY AND OCCURRENCE IT WAS DETERMINATE THAT NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE USE, A BD DISCARDIT¿ II SYRINGE MALFUNCTIONED AS ¿THE DRUG LEAKED OUT OF THE SYRINGE END, WHEN ASPIRATING FROM A CONTAINER WITH A RUBBER STOPPER.¿ THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89787 BD DISCARDIT¿ II SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 1709126

    Patients

    Seq Age Sex Outcome Treatment
    1 Other